BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1911453 · Received November 23, 2010

    Report

    Report Number
    3004464228-2010-01385
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 23, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WILL NOT BE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE CUSTOMER STATED THAT A KINK WAS SEEN IN THE CANNULA. THERE WAS, HOWEVER, NO REPORT OF AN OCCLUSION ALARM. THE POD WOULD HAVE INITIATED AN OCCLUSION ALARM IF THE FLOW OF INSULIN WAS RESTRICTED/PREVENTED BY THE KINK AND RESULTED IN BACK PRESSURE. THE OMNIPOD USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". IT ALSO SUGGESTS THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY IN ORDER TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE PT REMEDIED THE SITUATION BY REMOVING THE DEVICE PER USER INSTRUCTIONS AND HAD ADMINISTERED A MANUAL INJECTION OF INSULIN.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER EXPERIENCED HIGH BG LEVELS (413-481 MG/DL) WITH LARGE KETONES OVER THE 11 HOURS THE POD WAS WORN. DESPITE HAVING ADMINISTERED A CORRECTION BOLUS, HER LEVELS DID NOT LOWER. THE MOTHER STATED THAT "THE CANNULA WAS KINKED", THOUGH THE POD DID NOT INITIATE AN ALARM. THE POD WAS DEACTIVATED AND A MANUAL INSULIN INJECTION WAS ADMINISTERED. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other